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Is wGRS Associated With DD Recurrence?

Sponsor
University Medical Center Groningen (Other)
Overall Status
Completed
CT.gov ID
NCT02983162
Collaborator
(none)
427
Enrollment
1
Location
16.7
Actual Duration (Months)
25.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Rationale: Retrospectively reviewing the participants of the GODDAF database, revealed a significant association between the weighted genetic risk score and Dupuytren disease recurrence. However, a significant dose-response relation was not found. This might be caused by underestimating the recurrence rate, due to the retrospective nature of determining recurrence. Therefore, we want to do a follow-up measurement of the GODDAF participants, to see whether they suffered from recurrent disease.

Objective: We aim to determine whether the wGRS is associated with recurrent DD.

Study design: An observational study, in which the participants of the GODDAF study are followed up.

Study population: Patients affected by Dupuytren disease, aged 18-96 years, who were previously included in another study on the genetic basis of Dupuytren disease.

Intervention (if applicable): NA Main study parameters/endpoints: The main study parameter is the presence of recurrent Dupuytren disease.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    427 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Is the Weighted Genetic Risk Score Associated With Dupuytren Disease Recurrence?
    Actual Study Start Date :
    Mar 10, 2017
    Actual Primary Completion Date :
    Aug 1, 2018
    Actual Study Completion Date :
    Aug 1, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Presence of recurrent Dupuytren disease [1 day]

      there is only one measurement in this study

    Secondary Outcome Measures

    1. Severity of Dupuytren recurrence [1 day]

      there is only one measurement in this study

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • DD patient

    • participant in the GODDAF study

    • genetic data passed the quality control

    • surgical treatment of DD

    • written informed consent

    Exclusion Criteria:

    • Decisionally incapacitated

    • Patients treated for DD with collagenase or radiotherapy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Medical Center Groningen, dept Plastic Surgery Groningen Netherlands 9700 RB

    Sponsors and Collaborators

    • University Medical Center Groningen

    Investigators

    • Principal Investigator: P. MN Werker, MD, PhD, University Medical Center Groningen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    D.C. Broekstra, MSc, University Medical Center Groningen
    ClinicalTrials.gov Identifier:
    NCT02983162
    Other Study ID Numbers:
    • 201600670
    First Posted:
    Dec 6, 2016
    Last Update Posted:
    Feb 10, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Dupuytren Contracture
    Contracture
    Recurrence

    Study Results

    No Results Posted as of Feb 10, 2022